O’Byrne PM, FitzGerald JM, Bateman ED, Barnes PJ, Zhong N, Keen C, Jorup C, Lamarca R, Ivanov S, Reddel HK. Inhaled combined budesonide–formoterol as needed in mild asthma. New England Journal of Medicine. 2018 May 17;378(20):1865-76.
The topic of study we’ve chosen today falls into the umbrella of asthma and as we know asthma disease that affects many people in both the hospital and community settings as it stands the main state therapy of asthma includes the use of various types of inhalers and all that you use depends on the severity of your asthma this study focused on the treatment of
Mild asthma where mild asthma and that was over six years old is typically treated with a maintenance dose of inhaled corticosteroids as well as a sabot such as ventolin as needed this study but that typical regime into question and was one of three studies that prompted the change for the 2019 jeana guidelines to include the use of civil court where civil court
Would be used as a dd as needed monotherapy in those with mild asthma this study was conducted on the sample of 3849 patients aged 12 years or older who had received a clinical diagnosis of asthma at least six months prior it was required that these patients were classified as needing set to treatment according to the jeana guideline these patients were separated
Into three groups the intervention group being symbicort on an as-needed basis and to compare two groups one being a twice daily placebo what’s terbutaline as needed or twice daily the best night with terbutaline as needed the two major outcomes that were studied for one electronically recorded weeks number of weeks with well controlled asthma and two number of
Serve severe exacerbations the similar core group reported a 34.4 mean percentage of well controlled weeks whereas the terbutaline group demonstrated 31.1% however the united i maintenance therapy group purported 44.4% of weeks with well controlled asthma on the other hand the annual rate of severe exacerbations was 20% with terbutaline 9% would be denied and 7%
Symbicort given these results the yvette’s 9 maintenance therapy appears to be the best option for optimizing the control of asthma which was the primary outcome measured however symbicort may be the best option for the secondary outcome which is reducing the number of severe exacerbations that a patient would experience it suggests some appraisal points for the
Study itself so it was done on using a parallel rct as its structure which we think is the best one for the questions being asked the inclusion criteria appear to be reflective of the target population however pregnant and breastfeeding women as well as previous or current smokers were excluded from this site randomization was computer generated and the groups that
It created were very even both in the demographics and in the lung function and asthma severity the randomization was protected via double blinding and the only people that had access to this groups for the people that made the list and those that were packaging and labeling the products a full set analysis was done with the data and this means that all patients
Have a randomized and those that received the investigational product will be included in the analysis irrespective of their protocol here in spain completing participation in this study and then according to a chart that was given only 26 patients were lost to follow-up which is good as ice less than 1% of the size of population there are some concerns though as
Long to your bias may play a role that forgets to adherence so the adherence in all three groups was around 79% which is likely higher than what we can expect in community practice there is also a potential for reporting bias as the manufacturer of symbicort was the one that did the study i was also the analysis so a couple thoughts on how it can be applied so
As of right now it can be seen as another option to the standard maintenance dose steroid therapy symbicort may be especially useful and especially useful option for those who struggle with adherence using a maintenance inhaler and present as an option to reduce coracoid exposure and one last thing to sort of take note of is that simple court is currently under
Special authorization so future guidelines may impact this but as of right now the decision on whether to use symbicort will likely be cost dependent assuming that you don’t fit the criteria for special authorization so kind of like a bottom line summary there have been some consider are some concerns with regards to bias and study which do affect the validity
Of the results however this has been addressed and has been made clear by the researchers are involved in the study although as the methods that were used in the study are in our opinion a very valid for the purposes and the questions that were being asked the results of the studies show that simcorp use as needed might be valuable for some patients in certain
Cases such as decreasing rates of exasperation it may be less useful in controlling asthma as was noted in the results of the weeks with well controlled pathway the results seem to have high external validity as they are generalizable to a broad patient population due to the inclusion criteria as well the upcoming here are clinically important in a patient care
Setting and therefore can be applied to crimes in practice
Transcribed from video
Journal Club -Ryan, Joe, Kobe, Joey By Pharm 4620
